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ASH 2025 | MRD assessment as an early endpoint of treatment efficacy in AML: a PETHEMA registry study
Bruno Paiva, PhD, University of Navarra, Pamplona, Spain, discusses the potential of utilizing measurable residual disease (MRD) assessment as an early endpoint of treatment efficacy in acute myeloid leukemia (AML), building on the lessons learned from its use in multiple myeloma (MM). Dr Paiva highlights findings from a PETHEMA registry study, which included data from 2,623 newly diagnosed patients treated with intensive therapy in routine practice and clinical trials, and found MRD to be more sensitive than complete response (CR). This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
The outcomes that were achieved for example in myeloma regarding the use of MRD as an early endpoint of treatment efficacy in clinical trials as this was endorsed by the FDA in 2024 and by EMA in 2025. So what if not only in myeloma and CLL but also in AML, MRD could be used as an early endpoint of treatment efficacy. Now learning from the myeloma lessons if we want to use it in AML we need to clearly show that it is of higher sensitivity, superior to conventional complete response, that it has independent prognostic value, that it is applicable to patients regardless of cytogenetic risk, and that MRD-negative rates are to some extent associated with the impact that different treatments have on patient survival...
The outcomes that were achieved for example in myeloma regarding the use of MRD as an early endpoint of treatment efficacy in clinical trials as this was endorsed by the FDA in 2024 and by EMA in 2025. So what if not only in myeloma and CLL but also in AML, MRD could be used as an early endpoint of treatment efficacy. Now learning from the myeloma lessons if we want to use it in AML we need to clearly show that it is of higher sensitivity, superior to conventional complete response, that it has independent prognostic value, that it is applicable to patients regardless of cytogenetic risk, and that MRD-negative rates are to some extent associated with the impact that different treatments have on patient survival.
So in this very large study that leveraged on the huge data set collected by the PETHEMA group in Spain, we showed that MRD is indeed more sensitive than CR. Almost 70% of patients in CR have detectable MRD above the 0.01% threshold, and this is associated with inferior survival. We also show that it is of independent prognostic value regardless of induction as well as genetic risk. And we show that there is an association between different MRD negative rates with induction and the survival outcomes that patients have with those different induction regimens. This is not definitive data, but I think this is promising data suggesting that indeed MRD may have a role as an early endpoint of treatment efficacy for AML clinical trials.
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